NETHERLANDS Law and Practice Contributed by: Hamza Zourakhti and Barbara van der Ven, Brande & Verheij LLP
has to be made within 210 days after receiving the application (Article 44 (2) Medicines Act). This period can, in principle, be suspended if the MEB requests the applicant to provide additional information regard- ing the application. Applications for variations must be submitted to the MEB. A template cover letter (and recommendations for what to include in such letter) has been published on the MEB website. There are various types of vari- ations: Type IA, Type IB, Type II (and extensions), as mentioned in the Variation Regulation 1234/2008 (and as amended by Regulation (EU) 2024/1701). After an application for variations, the applicant receives a confirmation of receipt of the application. The follow- ing timelines apply: • For type IA variations, the MEB applies 60 days: 30 days for the validation and 30 days for any admin - istrative change for the marketing authorisation that might be required. • For type IB variations, the MEB applies 30 days for the validation and assessment of the application, 30 days for any clock-stop period and 30 days for the second assessment round. Type IB varia- tions should be approved by the MEB before the marketing authorisation holder may implement the changes. • For Type II variations, the MEB applies either 164 days or 194 days (for a new indication). In order to assist market parties with applications for variations, the MEB has published a useful Q&A on its website. Transfer of marketing authorisation requires prior authorisation. It is required to submit: • an accompanying letter and change request form; • a declaration that marketing authorisations are being transferred; • a statement that, with the exception of a new phar- macovigilance system, there are no changes to the marketing authorisation dossier; • an abstract from the Chamber of Commerce of the transferee;
• authorisations where applicable (eg, manufacturer/ retail/wholesale) to a new marketing authorisation holder; and • a modified SPC, labelling and package leaflet. Medical Devices There are no marketing authorisations in relation to medical devices. However, medical devices are divid- ed into four classes: Class I, IIa, IIb and III. The clas- sification rules are set out in Annex VIII of the MDR. In short, the class of a medical device is determined based on the level of invasiveness, the part of the body it is in contact with as well as the duration of the contact. In vitro diagnostic medical devices are also divided into various classes: Class A, B, C and D. The classification rules are provided for in Annex VIII of the IVDR. The classification of an in vitro diagnostic medical device depends on the intended purpose of the device as well as its risk profile. A medical device must bear a CE certificate if it is to be placed on the market in the Netherlands. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations Article 40 Medicines Act provides for several excep- tions from the requirement of a marketing authorisa- tion. These include, inter alia: • pharmacy preparations; • investigational medicinal products; • medicinal products that fall under the named patient arrangement; • medicinal products under the compassionate use programme (this requires the approval from the MEB); • ATMPs under the “hospital exemption” (their preparation and use is subject to approval from the IGJ); • parallel imports; • medicinal products that are provided with tem- porary approval by the MoH (for distribution) in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation; and • in-transit/export medicinal products (related to wholesale activities), which are not allowed to be
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